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Home » Topics » Regulatory

Regulatory
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FDA sends discordant signals with Global Harmonization Working Party withdrawal

Dec. 1, 2023
By Holland Johnson

The U.S. FDA opted not to pursue one form of medical device harmonization via the Global Harmonization Working Party (GHWP), as it reported it will withdraw from the organization.


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Regulatory actions for Nov. 30, 2023

Nov. 30, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Transit Scientific.
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Alpha-galactosidase enzyme
Endocrine/Metabolic

FDA clearance for first-in-human study of Uniqure’s AMT-191 for Fabry disease

Nov. 30, 2023
Uniqure NV has received FDA clearance of its IND application for AMT-191, the company’s gene therapy candidate for Fabry disease.
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Gene editing illustration
Immuno-oncology

KSQ’s CRISPR/Cas9 eTIL therapy IND cleared by FDA

Nov. 30, 2023
KSQ Therapeutics Inc., in collaboration with The University of Texas MD Anderson Cancer Center and the Cell Therapy Manufacturing Center (CTMC), have announced FDA clearance of an IND application for a phase I/II study of KSQ-001EX, KSQ’s lead engineered tumor-infiltrating lymphocyte (eTIL) program.
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Endocrine/Metabolic

CSPC Pharmaceutical’s SYH-2053 receives NMPA clearance for clinical studies in China

Nov. 30, 2023
CSPC Pharmaceutical Group Ltd.’s SYH-2053 injection has obtained clearance from China’s National Medical Products Administration (NMPA) to enter clinical trials in China.
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3D illustration of cancer in crosshairs
Cancer

Pasithea Therapeutics eyes IND filing for MEK1/2 inhibitor PAS-004 following FDA guidance

Nov. 30, 2023
Pasithea Therapeutics Corp. has received written responses from the FDA to questions submitted for a type 2 pre-IND meeting regarding the clinical development plan for PAS-004 (CIP-137401).
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Redhill shares climb eightfold on Talicia exclusivity

Nov. 29, 2023
By Karen Carey
Redhill Biopharma Ltd.’s stock (NASDAQ:RDHL) has soared in recent days following news that the U.S. FDA granted five years of market exclusivity for Talicia, a first-line therapy for eradication of Helicobacter pylori infection, which affects about 35% of the U.S. adult population.
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Brain and encephalography

US warns of safety issues from seizure medications; UK restricts valproate

Nov. 29, 2023
By Karen Carey and Mari Serebrov
The U.S. FDA put out a safety warning Nov. 28 that antiseizure drugs levetiracetam and clobazam can cause a rare but serious hypersensitivity drug reaction that may start as a rash but can progress to injure internal organs. In addition, U.K. health care providers are being told to get a plan in place now to implement the first phase of the Medicines and Healthcare products Regulatory Agency’s new regulatory measures  to reduce the risks of valproate, a treatment for epilepsy and bipolar disorder.
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COVID-19 mRNA vaccine vials, syringe

Japan approves first self-amplifying mRNA COVID-19 vaccine from CSL, Arcturus

Nov. 29, 2023
By Tamra Sami
In a global first, Japan's Ministry of Health, Labor and Welfare has approved CSL Ltd.’s and Arcturus Therapeutics Inc.’s self-amplifying messenger RNA (sa-mRNA) vaccine (ARCT-154) for COVID-19 in adults. The approval marks the first milestone for a November 2022 licensing deal under which CSL subsidiary CSL Seqirus in-licensed Arcturus’ late-stage sa-mRNA vaccine platform technology.
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Philips faces the heat with new thermal CPAP warning from FDA

Nov. 29, 2023
By Holland Johnson
Philips Respironics Inc.’s nightmares with its Dreamstation continuous positive airway pressure (CPAP) line of products continued with a fresh warning from the U.S. FDA of reports involving thermal issues with a newer iteration of the machine, some of which cited patient injuries.
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